Declaration of micro, small and medium-sized enterprise (SME) qualification

Declaration of micro, small and medium-sized enterprise (SME) qualification

The current criteria for SME assignment can be summarised as:

  • Fewer than 250 employees
  • Annual turnover not exceeding 50 million euro

(There are other factors to consider however)

The European Medicines Agency (EMA) provides very significant incentives for companies which meet the criteria for SMEs including:

  • Fee reductions for scientific advice meetings
  • Fee exemptions for certain administrative services
  • Deferral of the fee payable for an application for marketing authorisation or inspection;
  • Conditional fee exemption where scientific advice is followed and a marketing authorisation application is not successful;
  • Assistance with translations (into all 27 member state languages) of the product information in the application
  • Procedural assistance

To benefit from these incentives a company must submit a ‘declaration of SME qualification’ to the EMA comprising a signed form and supporting documents.  The information required is closely defined. For, example, enterprises which are linked to others with large financial resources may not qualify for SME assignment.

vector pharma can help by assessing your company’s circumstances, preparing the declaration and supporting documents promptly and efficiently and dealing with any matters arising.  The benefits of a successful declaration to your company’s regulatory affairs plans are very significant.